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China’s CapitalBio, Capetown’s CPGR to Offer Array Platform in Nascent S. African Market

The Centre for Proteomic & Genomic Research, a state-funded non-profit lab based in Capetown, South Africa, last week announced that it has signed a memorandum of understanding with Beijing-based CapitalBio to begin selling CapitalBio’s array platform in the African nation.
Under the terms of the agreement, CPGR will work as a reference site for CapitalBio products while looking to facilitate partnerships between CapitalBio and local researchers. The CPGR and CapitalBio have also agreed to apply CapitalBio’s existing tuberculosis-typing test for use in the South African market, and are keen to develop other tests upon demand.
Founded in 2006, CPGR has amassed a number of array platforms at its Capetown labs, from Affymetrix GeneChips to GenTel Biosciences antibody arrays. According to CPGR co-founder and managing director Reinhard Hiller, the CapitalBio agreement will give CPGR access to a low-cost diagnostics platform and a bevy of research tools necessary to fuel South Africa’s growing biotech sector.
“Molecular Diagnostics is one of our key focus areas in terms of driving new product development and in stimulating the biotech economy in South Africa,” Hiller told BioArray News this week. “CB has a range of instruments and products that are quite appealing in terms of costs, in particular when operating in a low-cost, emerging market. The latter is quite relevant in terms of developing diagnostic tests, for example,” he added.
Financial terms of the alliance were not disclosed.
TB and HIV
CPGR and CapitalBio’s first project will focus on tailoring CapitalBio’s TB test to meet the needs of Sub-Saharan Africa’s clinical laboratories and hospitals. According to Chen Ren, assistant director of business development at CapitalBio, the firm’s TB assay has been in development for four years. Ren told BioArray News this week that CapitalBio has “worked closely with the National Tuberculosis Reference Laboratory of the China Center for Disease Control and Prevention recently over the last year to validate the microarray-based assays.” 
CapitalBio’s TB test is organized into two kits: one for detecting TB and mycobacteria that analyses 17 different mycobacterial species found most frequently in clinical settings, and the other for detecting mutations in four genes implicated in resistance to the two most important anti-tuberculosis drugs — rifampicin and isoniazid. CapitalBio also provides automated array-analysis software with both kits.
According to Hiller, the CPGR and CapitalBio have already begun analyzing South African samples to understand how CapitalBio’s platform will perform in the African setting. 
“We’ll start with evaluating CB’s TB arrays against the background of local requirements, including diagnostic performance and cost efficiency from a local market point of view,” Hiller said.

“In China we see a rapid uptake [of microarray assays] once doctors understand the clinical benefits. We expect the same to be true of African countries.”

He said that CPGR is “working closely with leading experts in the TB field” in South Africa to evaluate the platform in a pilot study. “Assuming this goes well, the arrays could be used as they are or, what’s more likely, modified in terms of content — for example, composition of oligonucleotide probes targeting certain TB species — and adapted to the needs of the South African region prior to use them for research and diagnostic purposes,” Hiller said.
Because it is a non-profit, CPGR will most likely help modify and optimize the assay for the South African market and will deliver the finished assay to CapitalBio along with an undisclosed regional distributor who will commercialize and support the product. 
“We want to serve as a catalyst and get things moving,” Hiller explained. “We want to facilitate the optimization and facilitation of this technology for healthcare in South Africa.”
According to Hiller, CPGR and CapitalBio decided to focus on TB because of CapitalBio’s existing, validated assay, but also because TB is “one of the most pressing problems in South Africa.”
In 2006, the World Health Organization ranked South Africa fifth among the world’s 22 high-burden TB countries. According to the WHO’s Global TB Report 2006, South Africa, with a population of 47.9 million, had nearly 340,000 new TB cases in 2004 and an incidence rate of 718 cases per 100,000 people.
One key factor that could help local healthcare providers begin using CapitalBio’s assays is the platform’s relatively low cost. According to Hiller, a typical CapitalBio LuxScan 10K scanner, which produces 5-micron resolution images, sells for about $22,000, while some of the new higher-resolution, high-throughput scanners sold by firms like Tecan or MDS Analytical Systems, which offer 2-micron-level resolution, can cost up to five times that amount (see BAN 5/13/2008).
“Because [CapitalBio’s platform] is more affordable, it is more likely that people will use it, provided it comes with the same quality and performance,” Hiller said. Ren said that the TB assay has opened doors for CapitalBio in China’s clinical market, and that the firm, which has lacked a presence in Africa until partnering with CPGR, hopes to encounter a similar path to the South Africa market.
“Microarray assays are becoming commonplace in first-world diagnostics but are considered possibly a little advanced for developing countries,” Ren said. “Yet, in China we see a rapid uptake once doctors understand the clinical benefits. We expect the same to be true of African countries.”
If South African clinicians indeed begin using CapitalBio’s assays the partners may architect similar alliances for other diagnostic projects in the nation. Ren said that CapitalBio has a pipeline of tests, including one for hepatitis B drugresistance testing and a test designed to identify Gram-positive bacterial infections. However, the firm’s decision to debut these products in South Africa will hinge on local demand.
Hiller, meantime, expressed an interest in developing HIV tests, and perhaps assays for allergy testing — an area CPGR has been targeting since it was founded two years ago (see BAN 5/29/2007).
“In case the platform develops well, there is a possibility of developing new products in HIV and other diseases, but these projects have only been discussed very broadly and on a proof-of-concept basis,” Hiller said.
Plant Biotech and Beyond
Another potential area of collaboration for CPGR and CapitalBio is in the plant biotechnology arena. Ren said the center has expressed interest in the company’s plant miRNA array “as agricultural research is very important” for South Africa.
CapitalBio sells both mammalian and, more importantly for ag biotech, plant miRNA arrays, the latest version of which contain 426 non-redundant miRNA probes, according to the firm’s website.
“Plant biotechnology is one of the most relevant markets down here because plant biotech is so vital to the biotech community in South Africa,” Hiller said. “Modifying and growing crops is relevant to the long-term stability of populations in sub-Saharan Africa. You can use this technology as a means to an end to identify markers that can be used to identify certain traits.”
While a local plant miRNA-related project is in the cards, Hiller envisions using the new partnership with CapitalBio to move some of CPGR’s discoveries, particularly in the proteomics field, into the Chinese market through CapitalBio.
Hiller previously served as R&D director for Vienna, Austria-based VBC Genomics, where he helped to develop its Immuno Solid-Phase Allergen Chip. Jonathan Blackburn, CPGR’s research director, was founding scientist and CSO at Sense Proteomic and chief scientist at Procognia before joining the center.
“Based on our agreement with CapitalBio, we’ll gain access to existing CB technology, where we’ll explore opportunities to develop array-based applications with CB in non-communicable diseases and to develop protein-array based applications for CB, an area of technology that is particularly strong at the CPGR,” he said. “In doing the latter we’ll also explore the opportunity to gain access to the Chinese market, using CB as a partner.”

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